Bias in published randomized trials that compare collagenase injection with percutaneous needle fasciotomy in the treatment of Dupuytren disease: a systematic review.

Abstract

Purpose: Controversy exists regarding the comparative efficacy of collagenase injection and percutaneous needle fasciotomy in the treatment of Dupuytren contracture. The randomized controlled trials (RCTs) that have compared the two treatment methods have reported results mostly implying similar treatment efficacy, durability, and complications. We aimed to review these RCTs regarding methodical quality and risk of bias.

Methods: We searched PubMed and Cochrane Library databases up to May 2023. All RCTs comparing collagenase injection with needle fasciotomy were included. Eligible articles were reviewed by two researchers, of whom one was blinded to each article's title, authors, year of publication, journal, and source of the studies. To assess methodical quality, we used the modified Jadad scale yielding a score of 0 (lowest quality) to 5 (highest quality). We assessed risk of bias with the Cochrane risk-of-bias tool (RoB 2).

Results: Five studies were eligible, comprising 204 patients treated with collagenase injection and 209 patients treated with needle fasciotomy. The modified Jadad score ranged from 1 to 2 points in the five studies, and the overall risk of bias was high in all studies. Pretrial protocols could be retrieved for only two studies, revealing important discrepancies with the published articles.

Conclusion: The published RCTs that have compared collagenase injection with needle fasciotomy in the treatment of Dupuytren contracture demonstrate a high risk of bias.